FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT 2 WAVE GERMAN
MDR report key: 2243839
·
Received August 24, 2011
Report
- Report Number
- 1219856-2011-00307
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 23, 2011
- Report Date
- August 24, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH A SHEATH SUCCESSFULLY. DURING IAB THERAPY, THE PUMP SHUT DOWN. AS A RESULT THE RN RESTARTED THE PUMP, BUT THE SCREEN STAYED WHITE AND A CONTINUOUS NOISE SOUNDED. THE PUMP WAS SWITCHED OUT FOR ANOTHER PUMP (B)(4) WITH SUCCESS AND THE THERAPY CONTINUED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A TEN MINUTE DELAY OR INTERRUPTION IN THERAPY WHILE THEY SWITCHED PUMPS WITH NO HARM TO THE PT NOTED. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT'S OUTCOME IS OKAY. REQUESTED SUPPORT BY A THIRD PARTY SERVICE ORGANIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOCAT 2 WAVE GERMAN | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INTRA-AORTIC BALLOON |